Wounds and Injuries

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Pain

Radiodermatitis

Dermatitis

Skin Diseases

Radiation Injuries

Quality of Life

Analgesics

All Drugs and Chemicals

The medical device will be applied by the patient himself, after appropriate training carried out by the nurse, twice a day, in the quantity necessary to cover the lesion (0.2g of gel /16 cm2 of skin (one spray), repeated as many times as necessary to cover the entire lesion). The treatment will last 8 weeks.

The medical device will be delivered in the quantity strictly necessary to carry out the therapies between visits, in order to monitor its use. Patients will be seen weekly by the nurse, in order to ensure the best continuity of care and promote adherence to the study. Patients will be asked to keep a weekly diary, in which they will report their level of pain, analgesic therapy and medication. Nurses will be available for telephone counselling, if necessary.

This study has not got other intervention

Jalosome soothing gel

Testing the efficacy of the Jalosome® Soothing gel in 2 or 3 grade radiodermatitis healing in oncological patients.

The investigators would like to know also the efficacy of the device on quality of life and pain.

The overall objective of the study is to evaluate the efficacy of the class IIA medical device Jalosome® soothing gel in the healing of grade 2 or 3 radiodermatitis, in oncology patients undergoing radiotherapy treatment, during a 8-week observation period.

The secondary endpoints are radiodermatitis pain control and quality of life.

The investigators would like to involve 30 oncology patients. All oncology diagnosis will be included in this pilot study. The study will adopt a quasi-experimental design with one arm. The results will be used to determine the sample size for a clinical trial in which the class IIA medical device Jalosome® soothing gel will be compared to usual care.

The investigators would like to involve 30 oncology patients with 2 or 3 grade radiodermatitis (based on RTOG score).

All oncology diagnosis will be included.

Jalosome® Soothing Gel Efficacy Grade 2 or 3 Radiodermatitis.

The Efficacy of the Medical Device Jalosome® Soothing Gel in the Healing of Grade of 2 or 3 Radiodermatitis, Pain Intensity Reduction, as Well as Improvement of QoL in Oncology Patients: a Pilot Study.

The primary endpoint is the number of grade 2 or 3 radiodermatitis healed by the application of Jalosome® soothing gel during the observation period, out of the total number of patients treated. This endpoint will be assessed by photographic documentation of lesion improvement and healing and with the aid of the RGOT scale (which should regress from grade 2 or 3 to grade 0 or 1).

The time to regression of the lesion will also be monitored on this same endpoint in order to establish the rate of efficacy of the product against grade 2 and 3 lesions.

The first secondary endpoint will be the intensity and quality of pain, measured respectively by the NRS scale and by questions on the type of pain perceived (twinge, burning, pins, allodynia (i.e. a painful impulse following a harmless stimulus), cramp-like, piercing (stab-like)).

Quality of life will then be assessed as a second enpoint, using the Skindex questionnaire - 16

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Jalosome® Soothing Gel Efficacy Grade 2 or 3 Radiodermatitis.	NCT04692389	Radiodermatitis Oncology Quality of Life Pain	Jalosome soothi...	18 Years -	Welcare Industries SpA
Jalosome® Soothing Gel Efficacy Grade 2 or 3 Radiodermatitis.	NCT04692389	Radiodermatitis Oncology Quality of Life Pain	Jalosome soothi...	18 Years -	Welcare Industries SpA

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